Hydra Registry - Italy Experience

Last updated: May 13, 2025
Sponsor: Sahajanand Medical Technologies Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Hydra Transcatheter Aortic Valve System

Clinical Study ID

NCT05956652
Hydra-IT, V1.0, 02/03/2022
  • Ages 18-99
  • All Genders

Study Summary

Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with severe symptomatic native aortic valve stenosis and candidates for theTAVI procedure based on the evaluation of the Heart Team

  • Ability to understand and provide informed consent for inclusion in the study

Exclusion

Exclusion Criteria:

  • Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus orvegetation, endocarditis.

  • Refusal by the patient to participate in the study

  • High probability of non-adherence to required follow-ups

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Hydra Transcatheter Aortic Valve System
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
July 31, 2029

Study Description

Hydra-IT is a multicenter observational study conducted across different centres in Italy. The primary objective of the study is to evaluate the safety and efficacy of transcatheter aortic valve implantation and clinical outcome in patients treated with Hydra device. Secondary objective is to evaluate the long term (up to 5 years) effectiveness and the quality of treatment using Hydra device. Patients with severe stenosis symptomatic of the native aortic valve or bioprosthesis in a degenerated aortic position will be included in this study.

Connect with a study center

  • Fondazione Poliambulanza Istituto

    Brescia, 25124
    Italy

    Active - Recruiting

  • Montevergine Clinic, Mercogliano, Italy

    Mercogliano, 83013
    Italy

    Active - Recruiting

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    Milano, 20157
    Italy

    Site Not Available

  • Università degli studi di Padova

    Padova, 35122
    Italy

    Site Not Available

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